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Original Article

Formulation, characterization and

physicochemical evaluation of amoxicillin effervescent tablets
Abolfazl Aslani, Tahereh Sharifian

Department of Pharmaceutics, School of Pharmacy and Novel Drug Delivery Systems Research Center, Isfahan University of Medical
Sciences, Isfahan, Iran

Abstract Background: Amoxicillin is a semisynthetic antibiotic, which is used as an antimicrobial drug. This study
was designed to formulate amoxicillin effervescent tablets, aimed at improved patient compliance and
increased drug stability.
Materials and Methods: In this study, nine effervescent tablet formulations were prepared from amoxicillin
trihydrate. The effervescent base was comprised of various amounts of citric acid and sodium bicarbonate.
Powders and granules were evaluated for their particle size, bulk density, tapped density, compressibility
index, Hausner's ratio and angle of repose. The effervescent tablets were then prepared from powders
and granules of acceptable quality by direct compression and fusion methods. The tablets were evaluated
for weight variation, friability, pH of solution, carbon dioxide (CO2 ) content, hardness, effervescence time,
thickness, assay, content uniformity, water content and equilibrium moisture content.
Results: The results indicated better flowability of granules prepared by fusion method as compared with
the direct compression. The percent weight variation of tablets was within the acceptable limit of 0.5%.
The friability was less than 1% in all formulations. The solution pH of tablets prepared by direct compression
and fusion methods ranged from 4.55 to 5.74 and 4.74ÿ5.84, respectively. The CO2 amounts generated
by the fusion method tablets were smaller as compared to the direct compression method. The hardness
of tablets was 40.66ÿ56 for direct compression method and 60.6ÿ74.6 for fusion method. The tablets
produced by the fusion method have a larger thickness and lower water content than tablets produced by
the direct compression method.
Conclusion: Tablets prepared by the fusion method exhibited superior preÿ and postÿcompression
characteristics as compared to tablets prepared by direct compression method.

Key Words: Amoxicillin, direct compression method, effervescent tablets, fusion method

Address for correspondence:

Dr. Abolfazl Aslani, Department of Pharmaceutics, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.
Eÿmail: aslani@pharm.mui.ac.ir
Received: 27.01.2013, Accepted: 15.05.2013

Access this article online INTRODUCTION

Quick Response Code:

Website: As per revised definition proposed to US Food and Drug
www.advbiores.net Administration "effervescent tablets are tablets intended to
be dissolved or dispersible in water before administration."[1]
DOI: Effervescent tablets are uncoated tablets that contain acid
10.4103/2277-9175.143252 substances (citric, tartaric, malic acid or any other suitable
acid or acid anhydrate)

Copyright: © 2014 Aslani. This is an openÿaccess article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction
in any medium, provided the original author and source are credited.

How to cite this article: Aslani A, Sharifian T. Formulation, characterization and physicochemical evaluation of amoxicillin effervescent tablets. Adv Biomed Res
2014;3:209.

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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets
and carbonates or bicarbonates (sodium, potassium or
any other suitable alkali metal carbonate or bicarbonate)
that react rapidly in the presence of water by releasing
carbon dioxide (CO2 ).[2] Occasionally, an active ingredient
itself could act as the acid or alkali metal component for
effervescent reaction. Effervescent tablets have some
advantages over suspension dosage forms. They are
already in solution at the time they are consumed; Thus,
the drug absorption is faster and more complete. Faster
absorption means faster onset of action so, they are
helpful in treating acute symptoms such as infections and
pain.[3ÿ5] They are more easily transported; good stability
is inherent with the effervescent formulations. This kind of
drug delivery has predictable and reproducible
pharmacokinetic profiles.[6] Effervescent systems provide
a pleasant taste in comparison to liquids, mixtures and
suspensions because carbonation helps to mask the bad
taste of drugs and effervescent tablets retain their flavor
after lengthy storages.[7] Effervescence reaction is favored
by many patients, especially children; thus, patients are
more likely to complete their course of treatment.[8]
Furthermore, some pharmaceuticals such as antibiotics
and amino acids are sensitive to changes in gastric pH
and low gastric pH can lead to their destruction, resulting
in their reduced activity. Effervescent products can
increase gastric pH and avoid or minimize the destruction
of materials, prone to gastric pH.[9ÿ11]
Amoxicillin (ÿÿaminoÿhydroxy benzyl penicillin) is a
semisynthetic antibiotic; belongs to ÿÿlactam family.
Amoxicillin is effective against many different bacteria
including Heamophilus influenza, Neisseria gonorrhea,
Escherichia coli, Salmonella, Proteus mirabilis,
Enterococci, Streptococci, Listeria, Helicobacter
pylori and certain strains of Staphylococci. It inhibits
crossÿlinkage between peptidoglycan polymer chains that
make up a major component of the cell walls of both
gramÿpositive and gramÿnegative bacteria.
Amoxicillin is used for infections of middle ear, tonsils,
upper and lower respiratory tract, urinary tract, skin and
stomach in adult and pediatric patients.[12ÿ14]
Amoxicillin is commercially available in trihydrate form.
Amoxicillin is used as powder for suspension at two
strengths of 125 mg and 250 mg in children. An important
disadvantage of suspensions is interÿdose variability, often
seen when patients forget to shake the bottle before taking
the medication. Phase separation and difficulty of
reconstituting suspension are other problems of the
dosage form. The therapeutic effect of amoxicillin
suspensions may change and decline from the 1st day to
the last day of treatment. In addition, patients may avoid
carrying the medication with them when away from home,
resulting in poor compliance and the failure of therapy.
2 Advanced Biomedical Research | 2014
Therefore, this study was designed to develop effervescent
tablets as an alternative dosage form of amoxicillin for
achieving improved patient compliance and drug stability.
MATERIALS AND METHODS
Chemicals
Amoxicillin trihydrate was provided from Farabi
Pharmaceutical Company (Isfahan, Iran).
Sodium bicarbonate, citric acid, tartaric acid,
polyvinylpyrrolidone (PVP), mannitol, aspartame and
polyethylene glycol (PEGÿ6000) were provided from Merck
Company (Germany).
Preparation of the standard curve of amoxicillin
trihydrate
A total of 10 mg amoxicillin was added to phosphate buffer
pH 5 in a 100 ml volumetric flask to obtain drug
concentration of 100 µg/ml. From this solution,
concentrations of 10, 15, 20, 25, 30 and 40 µg/ml were
made and their absorbances were determined by an
ultraviolet spectrophotometer at 229.8 nm against blank.
This experiment was repeated for 3 days to evaluate intra
and inter day variations.[15]
Direct compression method
Fine powder of amoxicillin trihydrate was prepared to slug.
Then, the slugs are crushed and passed through a sieve
No. 20. Other components were weighed and mixed with
amoxicillin granules to obtain a homogeneous powder.
Finally, lubricant (PEG 6000) was added to the mixed
powder.[5,16]
Fusion method
Certain amounts of citric acid and sodium bicarbonate
were mixed together and heated at 54°C for about 15 min.
The granules were dried for ½ h in the oven at 60°C.
Finally, amoxicillin dry granules and remaining ingredients
of formulation were added and mixed, to which the
lubricant was added.[16,17]
Preÿcompressional evaluation
Determination of particle size
Sieve method was used for this test. Sieves of different
meshes (20, 25, 30, 35, 40, 70 and 100) were selected
and placed on top of each other. 100 g of powder was
placed on the upper sieve. After 10 min of mild shaking
the amount remaining on each sieve was collected.
Average diameter of powder was calculated by the following equation:[1
ÿ
d = x in
i 100
xi = Average size of both the upper and lower sieve
di = Percent of the value i in that range of bulk.
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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets

Bulk density fall outside the percentage limit and none of tablets differ by
A quantity of accurately weighed powder from each formula more than double percentage limit.[6,21]
was introduced in to the measuring cylinder and then the
volume was noted. Bulk density was expressed in g/ml and Friability
determined by the following formula:[20] A total of 20 tablets were weighed and placed in the friabilator
(Erweka, TAP, Germany) and then operated at 25 rpm for 4
min. The tablets were then weighed again. The difference in
m the two weights was used to calculate friability as follows:[15]
ÿ bulk=
V bulk

Friability percent = (Weight of tablets before test ÿ Weight

Tapped density after test)/(Weight of tablets before
A quantity of accurately weighed powder from each formulation test) ×100.
was introduced into a measuring cylinder.
The cylinder was hit from the height of 2.5 cm every 2 s, up pH of solution
to the volume plateau. Tapped density was calculated from One tablet was dissolved in purified water. After complete
the following formula:[20] dissolution, the solution pH was measured by a pH meter
(Metrohm, 632, Switzerland). This test was repeated 3 times
m
ÿ tapped = for each formulation.[19]
V tapped
Carbon dioxide content
One effervescent tablet was dissolved in 100 ml sulfuric acid
Compressibility index and Hausner's ratio
1 N and weight variation was measured before and after
These terms explain flow properties of the powders.
Compressibility index was expressed in percentage. dissolution. CO2 content was presented as mg. This
experiment was conducted on three tablets for each
They were given by the following equation:[15] formulation.[19]
[ÿ ÿtapped - bulk ]
Compressibility Index = 100 × Hardness
ÿ tapped
The tablet hardness was determined by Erweka (24ÿTB,
Germany).[6,15]
ÿ tapped
Hausner'sRatio =
ÿ bulk Effervescence time
A tablet was placed in a glass containing purified water and
effervescent time was measured by a stopwatch.[19]
Angle of repose
It was measured by fixed funnel method. A funnel was
secured with its tip at a given height H, above graph paper Thickness

that was placed on a flat horizontal surface.
Granules were carefully poured through the funnel until the
apex of the conical pile just touched the tip of the funnel. The
angle of repose (ÿ) was then calculated by measuring the
height (h) and radius (r) of the heap of the formed powder or
Thickness was measured using a calibrated dial caliper. 10
tablets of each formulation were evaluated.[7]
Assays

granules and putting the values in the equation.[20] A tablet was placed in a 100 ml volumetric flask and dissolved
in phosphate buffer pH 5. After dilution, the amount of the
drug was determined by UV spectrophotometer at 229.8 nm
hight against blank. 10 tablets of each formulation were evaluated.
tan =( )0.5
ÿ
Base [15,20]

Content uniformity
Where, ÿ = Angle of repose. After selecting 10 tablets randomly, the content of each tablet
was separately determined. Then, the above procedure was
Postÿcompressional evaluation followed.[15]
Weight variation
Twenty tablets were weighed individually and the average Water content
weight was calculated. The individual weights were then A total of 10 tablets of each formulation were weighed before
compared with the average weight. The tablets will pass the and after placing in a desiccator containing activated silica gel
test if not more than two tablets for 4 h. The percentage of their

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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets

water content was calculated from the following equation:
[19]
Water content =
weight before drying -weight after drying
weight before drying
Equilibrium moisture content
Three tablets were placed in three desiccators containing
saturated saline solutions, potassium nitrate relative
humidity (RH, 90%), sodium chloride (RH, 71%) and
sodium nitrite (RH, 60%) at 18°C. After 1 and 7 days,
the percent equilibrium moisture content was determined
by the KarlÿFisher method using Autotitrator instrument
(Mettler, TOLEDOÿDL 53, Switzerland).[19,22]
RESULTS
concentrations ranging from 10ÿ40 µg/ml. Formulations
consisting of different stochiometric ratios of citric acid,
tartaric acid and sodium bicarbonate were made to
determine the pH at which amoxicillin trihydrate has a
ÿ 100
greater solubility. Formulations are listed in Table 1. In
P1 ÿP4 formulations, the amount of citric acid
and sodium bicarbonate were fixed and the amount
of tartaric acid was changed. In P5 ÿP9 , the amount of
sodium bicarbonate was fixed and the amount of citric
acid was changed according to the previous results. In
P10ÿP18, tartaric acid was omitted from the formulation
and the amounts of citric acid and sodium bicarbonate
were changed.
Table 2 shows the process of effervescent tablets of
amoxicillin, prepared by two methods of direct
compression and fusion. Tables 3 and 4 show the
results of preÿcompression tests on the mixed powders.

The standard curve of amoxicillin trihydrate was linear Tables 5 and 6 show the postÿcompression tests results
(y = 0.026 + 0.3903 [R2 = 0.9986]) at on tablets. The percent weight variations of all
formulations were within the acceptable limits of 0.5%
Table 1: Preformulation of amoxicillin effervescent tablets of the weights. The friability was less than 1% in all
Preformulation Citric Tartaric Sodium pH *Solubility
formulations. In direct compression method, the pH was
number acid acid bicarbonate between 4.55 and 5.74 and for the fusion method was
1 88 175 298 6.6 1 between 4.74 and 5.84.
2 88 133.5 298 6.47 2 The CO2 content of the tablets produced by fusion
3 88 87.5 298 6.3 2 method was lower as compared to that of tablets
4 88 43.7 298 6.16 3 prepared by direct compression method. The hardness
5 176 175 298 5.92 3 of the tablets was found to be 40.66ÿ56 for direct
6 176 87.5 298 5.5 3 compression method and 60.6ÿ74.6 for fusion method.
7 132 87.5 298 5.43 3
The tablets produced by the fusion method were thicker.
8 44 87.5 298 5.8 3
Water content in the tablets produced by direct
9 0 87.5 298 6.88 1
compression method was higher.
10 88 ÿ

298 6.9 1
11 88 223.5 6.5 1
DISCUSSION
ÿ

12 88 ÿ

149 5.9 2
13 132 298 6.48 1
Active pharmaceutical ingredients can be formulated as
ÿ

14 132 ÿ

223.5 5.9 3
effervescent tablets if they have specific characteristics
15 132 ÿ

149 5.3 5
including quick aqueous dissolution and absorption in
16 176 ÿ

298 6.2 3
the gastrointestinal tract. Amoxicillin is available in the
17 176 ÿ

223.5 5.49 4
market as powder for suspension at 125 mg and 250
18 176 ÿ

149 5.17 5
*Solubility using a standard table[22] (1=Insoluble; 2=Slightly soluble; 3=Sparingly
mg/5 ml strengths for children. Furthermore, effervescent
soluble; 4=Soluble; 5=Freely soluble) tablets are attractive and better

Table 2: Composition of effervescent tablets prepared by direct compression and fusion methods
Ingredients Formulations

F9

Amoxicillin F1 143.5 F2 143.5 F3 143.5 F4 143.5 F5 143.5 F6 287 F7 287 F8 287 287
Citric acid 176 176 132 264 132 198 220 264 330
Sodium bicarbonate 149 223.5 223.5 232.5 149 223.5 223.5 298 375.5
Mannitol 200 200 200 200 200 200 200 200 200
PVP 28 32 30 43 32 45 45 51 60
PEGÿ6000 4.4 3.8 3.6 5.5 4.4 5.8 5.8 6.4 7.3

Aspartame 15 30 30 20 10 50 50 60 80
PVP: Polyvinylpyrrolidone, PEG: Polyethylene glycol

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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets

tolerated by patients and amoxicillin is not available in
this form. We decided to formulate and research
amoxicillin trihydrate effervescent tablets.
According to European Pharmacopeia, amoxicillin
trihydrate has a low solubility in water but good solubility
in dilute acid and hydroxide solutions.
Different formulations were made from the combination
of citric acid, tartaric acid and sodium bicarbonate.
When tartaric acid was employed to a greater extent
than citric acid, the resulting solution was turbid and a
large amount of sediment remained in the bottom of the glass.
When only citric acid was used as the acid ingredient,
the resulting solution was clear and no sediment was
remaining, but when tartaric acid was used, the resulting
solution was turbid and a large amount of

Table 3: Physical characteristics of the mixed powders in direct compression method

Characteristics of Formulations
powders F1 F2 F3 F4 F5 F6 F7 F8 F9

Bulk density (g/ml) 0.71 0.623 0.70 0.615 0.8 0.50 0.533 0.453 0.546

Tapped density (g/ml) 0.884 0.77 0.816 0.683 0.847 0.619 0.718 0.568 0.668

Compressibility index (%) 19.68 19.09 14.21 9,956 5,549 19.22 25.76 19.24 18.26
Hausner's ratio 1,245 1,236 1,119 1.10 1,059 1,238 1,367 1.22 1,223

Angle of repose 40 38.3 34.2 29.6 28.5 42.4 46.6 37.8 38.6

Table 4: Physical characteristics of the mixed granules in fusion method

Characteristics of Formulations
powders G9
G2 G3 G4 G5 G6 G7 G8
Bulk density (g/ml) G1 0.62 0.610 0.641 0.587 0.791 0.489 0.518 0.432 0.533

Tapped density (g/ml) 0.762 0.697 0.732 0.643 0.830 0.595 0.688 0.536 0.642

Compressibility index (%) 18.63 12.48 12,191 8.70 4.69 17,815 22.70 18.40 16.97
Hausner's ratio 1.22 1,142 1,138 1,093 1.04 1.21 1,308 1.22 1,204

Angle of repose 37.8 33.4 32.2 26.6 25.6 34 41.7 36.6 36.9

Table 5: Physicochemical characteristics of tablets produced by direct compression method

Tablets characteristics Formulations

F8 F9

Weight variation (g) F1 0.709 F2 0.841 F3 0.758 F4 0.895 F5 0.654 F6 0.995 F7 0.998 1.10 1,324

Friability (%) 0.69 0.65 0.63 0.59 0.53 0.75 0.78 0.83 0.81

pH of solution 5.1 5.4 5.9 5.48 5.74 4.55 5.18 4.99 5.11

CO2 content (mg) 580.3 559.6 461 497.3 472 648 882.3 797.6 918

Hardness (N) 51.33 47.33 42 46 45.3 50 40.66 41.66 56

Effervescence time (sec) 90.6 95.6 93.6 100.3 96.7 102.6 117.6 111.7 114

Thickness(mm) 3.58 3.62 3.22 4.35 3.31 4.42 4.73 5.1 5.36

Assay (mg) 126.2 124.5 126.2 125.4 126.7 251.4 251.08 252.8 251.4

Content uniformity (mg) 125.4 125.5 126.0 126.2 126.3 250.8 251.9 250.3 251.8

Water content (g) 0.046 0.062 0.036 0.045 0.045 0.034 0.028 0.033 0.034

Table 6: Physicochemical characteristics of the tablets produced by fusion method

Tablets characteristics Formulations

G2 G3 G4 G5 G6 G7 G8 G9

Weight variation (g) G1 0.696 0.845 0.760 0.887 0.653 0.995 1.04 1.14 1,338

Friability (%) 0.45 0.42 0.46 0.50 0.43 0.56 0.58 0.58 0.60

pH of solution 5.19 5.45 6 5.47 5.84 4.54 5.11 4.97 5.17

CO2 content (mg) 571 519 420.3 460 400.6 619.6 517 626.3 891

Hardness (N) 63.6 68.7 64.3 60.6 68 73.6 69.3 70.6 74.6

Effervescence time (sec) 105.3 111.6 110.6 111.3 116.6 118.5 116.6 114.6 118

Thickness(mm) 3.61 3.76 3.33 4.42 3.34 4.47 4.82 5.24 5.44

Assay (mg) 125.4 126.7 126.5 125.8 125.9 250.06 249.6 251.0 250.4

Content uniformity (mg) 125.4 125.6 126.1 125.33 126.2 250.4 251.2 251.8 251.6

Water content (g) 0.014 0.020 0.014 0.025 0.015 0.015 0.014 0.013 0.015

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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets
sediment was remaining. Consequently, tartaric acid
was omitted from the effervescent base formulation.
Preÿformulation studies indicated that amoxicillin had
greater solubility at pHs about 5. The effervescence
time was also determined. Thus, formulations that
produced lower amounts of sediment were selected.
The effervescence time for effervescent tablets is
directed in the British Pharmacopeia to be measured in
200 ml water. However, the amount of water used in
our testing was decreasing as possible.[19] Since the
dosage forms developed were aimed at children, we
demonstrated in preÿformulation tests that an
effervescent tablet of amoxicillin trihydrate could be
dissolved in 50 ml water. Thus, the following tests were
carried out in 50 ml water.
To increase amoxicillin solubility PVP was used. The
amount of PVP was increased from 1% to 6%, at which
only a very small amount of sediment was produced
that was dissolved over 1 min.[23] Furthermore, water
temperature has a direct effect on the dissolution of
effervescent tablets.
The size of the solid particles in pharmaceutical products
is the most important factor to achieve a desired
pharmaceutical product. The effervescent granules
have larger particle size than that of the effervescent
powders. The mean diameters in F1 ÿF9 formulations
were 299.54ÿ392.79 µ and for G1ÿG9 formulations
were 322.63ÿ414.22 µ. All formulations have normal
distribution. Normal distribution graphs of the formulation
1 for the both methods are shown in Figures 1 and 2.
Previous studies also reported similar findings.[23,24]
Bulk and tapped densities in granules due to increased
porosity and decreased cohesion force were less than
that of the powders. The results are shown in the Tables
4 and 5. Granulation by fusion method produced
granules with lower tendency for adhesion, due to their
lesser moisture content. On the other hand, the larger
particle size of granule
Figure 1: Particle size distribution of F1 granules prepared by direct compression method
6 Advanced Biomedical Research | 2014
than powders resulted in decreasing contact area of
particles. Therefore, friction between particles decreases
and so flowability increases. Angle of repose in the
formulations of effervescent granules was in the range
of 30ÿ45, indicating acceptable to good flowability.
Other studies suggested similar findings.[23,24]
The maximum percentage of weight variation was 5%,
which was within the acceptable range of the USP.
Weights of tablets prepared by the two methods were
not out of this range. One of the main reasons for weight
uniformity is appropriate flowability of powders.
Tablets prepared from the effervescent granules have
small weight variations due to their better flowability.
Actually, granules are secondary particles that are made
from the primary particles and have a porous structure.
Therefore, in addition to physical changes in the primary
particles, the physical changes in the granules provided
better compressibility of granules, resulting in the
production of the effervescent tablets of suitable
hardness.
However, the hardness of tablets cannot demonstrate
the physical strength of tablets exclusively. To evaluate
the physical strength of tablets, in addition to the
hardness test, the friability test was also performed.
Owing to the light weight of the tablets, all formulations
have friability of less than 1%. In the other studies we
showed that wet granulation technique could improve
compressibility and flowability properties and hardness
that the results were in agreement with this study.[23,24]
Since amoxicillin showed a greater solubility at pH 5,
the pH of all formulations was adjusted around this
value. This pH increases gastric pH temporarily,
resulting in shorter gastric residence time of the dosage
form. Therefore, drugs can be absorbed from the small
intestine more effectively. In other studies on effervescent
granules containing citric acid and sodium bicarbonate
have been done solutions pH,
Figure 2: Particle size distribution of G1 granules prepared by fusion method
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Aslani and Sharifian: Formulation of amoxicillin effervescent tablets
Table 7: Equilibrium moisture content (%) in the effervescent powder and granular mixture of the F3 and G9 at temperature 18°C
Formulations Microclimates Powder effervescent mixing 1st
(%) Day 7th Day 9.36 (0.01)* 16.5
F3 RH 90 (0.02) 5.04 (0.02) 12.70 (0.02) 4.35
RH 71 (0.01) 7.49 (0.01) 11.35 (0.01) 16.46
RH 60 (0.01) 8.61 (0.01) 10.67 ( 0.02) 5.19
G9 RH 90 ( 0.01) 8.88 (0.01)
RH 71
RH 60
*Mean (standard deviation), n=3, The saturated salt solutions: Sodium nitrite (RH, 60%), sodium chloride (RH, 71%), and potassium nitrate (RH, 90%)
which is obtained from dissolving granules, was
measured at about 5.8. It is comparable to the results
in this study.[23,24]
The CO2 content of the effervescent granules was less
than that of the effervescent powders. This difference
may be caused by the manufacturing process of the
granules. In the fusion method, water can be released
during the process, mediating production of CO2 due to
the reaction of partial amounts of citric acid and sodium
bicarbonate present in the formulation. The amount of
gas depends on the amount of base too.
Effervescence time was between 90.6 s and 114 s for
the direct compression method and between 105 s and
118.5 s for the fusion method, these ranges were
acceptable for both methods according to the British
Pharmacopeia.[19] The shorter effervescence time of
tablets produced by the fusion method basically reflects
the impact of the process employed.[24]
As compared to the direct compression method, tablets
produced by the fusion method were thicker due to
greater internal porosity of the granules. Tablets had
uniform thickness, which shows that the force used by
the tableting machine was uniform.
All formulations had passed assay test successfully.
Content uniformity was in an acceptable range, which
shows powders and granules were uniformly mixed
before tableting.
During drying stage in the fusion method, the unbound
water in granules is evaporated, which results in a lower
than tablets produced by the direct compression method.
The water content of all effervescent tablet formulations;
however, was in the acceptable range of 5% or less.
Equilibrium moisture content of a solid is exposed to
ambient air changes by changing RH. Formulations of
effervescent granules absorb more moisture because
they lose their water in the fusion procedure [Table 7].
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Variation (%w/w) Effervescent granules 1st Variation (%w/w)
Day 7th Day
43 13.31 (0.01) 20.70 (0.02) 6.97 35
60 (0.01) 14.62 (0.01) 5.51 (0.02) 52
42 8.58 (0.01) 15.64 (0.02) 28.35 35
31 (0.02) 11.31 (0.01) 17.74 (0.01) 44
19 9.42 (0 .01) 12.14 (0.02) 36
41 23
CONCLUSION
Effervescent amoxicillin trihydrate tablets were prepared
by two methods as alternative dosage forms for
treatment of bacterial infections in children.
It can be concluded from the results of this study that
granules from the fusion method have better flowability
and compressibility. Tablets of both dose strengths
prepared by the fusion method had better physical
characteristics as compared to those prepared by the
direct compression method. Amoxicillin showed highest
solubility at pH 5. Increasing PVP content of the
formulations increased the drug solubility. Our
preliminary studies indicate that, in general, the
effervescent formulations of amoxicillin exhibit
acceptable compendia characteristics and can be
introduced as an alternative to amoxicillin suspension,
following further investigations.
ACKNOWLEDGMENT
This study was supported by Isfahan University of Medical
Sciences as a thesis research project numbered 390180.
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Source of Support: This study was supported by Isfahan University of
Medical Sciences as a thesis research project numbered 390180, Conflict
of Interest: None declared.